Surrogate endpoints in trials: a call for better reporting

Ciani, O., Manyara, A. M. , Chen, A.-W. and Taylor, R. S. (2022) Surrogate endpoints in trials: a call for better reporting. Trials, 23, 991. (doi: 10.1186/s13063-022-06904-7) (PMID:36503559) (PMCID:PMC9743760)

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Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the reporting of these trials. We would like to invite interested individuals (trial methodologists, journal editors, healthcare industry, regulators and payers, and patient/public representative groups), particularly those with experience in the use of surrogate endpoints in trials.

Item Type:Articles
Glasgow Author(s) Enlighten ID:Ciani, Professor Oriana and Manyara, Dr Anthony and Taylor, Professor Rod
Authors: Ciani, O., Manyara, A. M., Chen, A.-W., and Taylor, R. S.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
Journal Name:Trials
Publisher:BioMed Central
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2022 The Authors
First Published:First published in Trials 23: 991
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
313399Reporting of randomised trials using surrogate outcomes: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statementsRodney Stephen TaylorMedical Research Council (MRC)MR/V038400/1HW - MRC/CSO Social and Public Health Sciences Unit